A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106574
• Other study ID #: WA18063
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2005
• Last updated: November 1, 2016
• Start date: April 2005
• Est. completion date: December 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1220
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients at least 18 years of age with moderate to severe active RA for at least 6 months;

• inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;

• stable DMARD therapy for at least 8 weeks before entering study;

• patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

• major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;

• patients who have previously failed treatment with an anti-tumor necrosis factor agent;

• women who are pregnant or breast-feeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Signs and Symptoms

Intervention

Drug:
• Placebo
iv every 4 weeks
• tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  Costa Rica,  Czech Republic,  Finland,  France,  Germany,  Hong Kong,  Mexico,  Panama,  Russian Federation,  South Africa,  Spain,  Sweden,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with ACR 20 response		Week 24	No
Secondary	Percentage of patients with ACR 50 and ACR 70 responses.		Week 24	No
Secondary	Mean changes in parameters of ACR core set		Week 24	No
Secondary	AEs, laboratory parameters, vital signs.		Throughout study	No